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Nebulizer (Direct Patient Interface)

Regulation 868.5630

4510(k)s in 12 months (509 all time)
0recalls in 12 months (36 all time)
25recalls that name a 510(k)
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Top companies in CAF

Company510(k)sRecalls
Airlife, Inc.160
Aerogen Limited94
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company013
Vortran Medical Technology 1, Inc.120
Salter Labs92
Thayer Medical Corp.92
Adherium (Nz), Ltd.100
Reciprocal Labs100
Omron Healthcare, Inc.71
Pari Innovative Manufacturers, Inc.80
Decided510(k)Device and applicantCode
Feb 28, 2018K173367MC 300* Nebulizer
Trudell Medical International, CA
CAF
Nov 28, 2017K170916Portable Nebulizer
Microbase Technology Corporation, TW
CAF
Nov 2, 2017K170853InnoSpire Go
Respironics Respiratory Drug Delivery (Uk) , Ltd., GB
CAF
Sep 6, 2017K161586The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
Shenzhen Homed Medical Device Co., Ltd., CN
CAF
Aug 30, 2017K163485SmartTouch
Adherium (Nz), Ltd., NZ
CAF
May 17, 2017K153748AirLife Misty Finity Nebulizer
Care Fusion
CAF
May 2, 2017K162041Airworks Nebulizer pe1200m
Convexity Scientific, LLC
CAF
Apr 14, 2017K162785Velox Nebulizer System
Pari Respiratory Equipment, Inc.
CAF
Feb 28, 2017K162753RTC 26-C Inline Aerosol Adapter
Instrumentation Industries, Inc.
CAF
Nov 1, 2016K161454Propeller Sensor Model 2015-E
Reciprocal Labs Corporation
CAF
Jul 26, 2016K153010Hudson RCI AquaPak Sterile Prefilled Nebulizers
Teleflexmedical, Inc.
CAF
Mar 8, 2016K152882Propeller System
Reciprocal Labs
CAF
Mar 4, 2016K152482Propeller Sensor Model 2014-R
Reciprocal Labs
CAF
Jan 22, 2016K142541POCKET NEB
Microvaper Devices
CAF
Jul 10, 2015K143719Aeroneb USB Contoller System
Aerogen Limited, IE
CAF
Jun 30, 2015K150591Besmed Reusable Jet Nebulizer
Besmed Health Business Corp, TW
CAF
Jun 19, 2015K143671Propeller Model 2014-D Sensor
Reciprocal Labs
CAF
May 15, 2015K142516Propeller System
Reciprocal Labs Corporation
CAF
Apr 29, 2015K142153HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
Teleflexmedical, Inc.
CAF
Mar 5, 2015K142960Propeller System 2014-R
Reciprocal Labs
CAF
Jan 9, 2015K142059FOX MOBILE
Vectura GmbH, DE
CAF
Jan 8, 2015K140237DISPOSABLE NEBULIZER SET
Suzhou Weikang Medical Apparatus Co., Ltd., CN
CAF
Dec 18, 2014K141214AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
Teleflexmedical, Inc.
CAF
Oct 17, 2014K133360AERONEB SOLO; AERONEB SOLO ADAPTER
Aerogen, Ltd., IE
CAF
Sep 30, 2014K141140COMP A-I-R
Omron Healthcare, Inc.
CAF
Aug 15, 2014K140919RESPICONNECT ADAPTER
Trudell Medical Int'L, CA
CAF
Jun 24, 2014K133105BREEZE NEBULIZER (NBR-10X)
Digio2 International Co., Ltd., TW
CAF
May 30, 2014K140211ULTRASONIC MESH NEBULIZER
Foshan Gaunying Electronics Co., Ltd.
CAF
May 2, 2014K140638PROPELLER SYSTEM - MODEL 2
Reciprocal Labs Corporation
CAF
Apr 25, 2014K133951SMARTTOUCH
Nexus6, Ltd., NZ
CAF
Jan 8, 2014K132247ULTRASONIC MESH NEBULIZER
Foshan Gaunying Electronics Co., Ltd.
CAF
Dec 19, 2013K123030COMPRESSOR NEBULIZER MODEL MCN-S600XX
Dongguan Aidisy Machinery & Electronic Equipment C
CAF
Oct 9, 2013K130379ROLLINS 7 OXYGEN MASK
Rollins Medical Solutions, Inc.
CAF
Apr 25, 2013K123527AIRLIFE
Care Fusion
CAF
Apr 17, 2013K121770HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
Headstar Medical Products Co., Ltd., TW
CAF
Mar 21, 2013K122060CLEVER TD-7001NEBULIZER
Taidoc Technology Corporation, TW
CAF
Mar 15, 2013K121520ULTRASONIC NEBULIZER (MESH TYPE)
K-Jump Health Co., Ltd., TW
CAF
Mar 13, 2013K130091PULMOSAL
Pharmacaribe
CAF
Mar 11, 2013K123614SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
Trudell Medical Intl., CA
CAF
Feb 28, 2013K121969U-RIGHT COMPRESSOR NEBULIZER
Taidoc Technology Corporation, TW
CAF
Nov 7, 2012K122857HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
Pegasus Research Corp.
CAF
Aug 20, 2012K121154ULTRASONIC NEBULIZER
Foshan Gaunying Electronics Co., Ltd.
CAF
Aug 10, 2012K111246SPIRALE DRUG DELIVERY SYSTEM
Armstrong Medical , Ltd., IE
CAF
Jul 2, 2012K121609ASTHMAPOLIS SYSTEM
Reciprocal Labs Corporation
CAF
Jun 21, 2012K112824QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
Quality Life Technologies Co;Ltd
CAF
Jun 19, 2012K113033SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
Nephron Pharmaceuticals Corp.
CAF
May 30, 2012K112859ERAPID NEBULIZER SYSTEM
Pari Respiratory Equipment, Inc.
CAF
Apr 26, 2012K120939AERONEB PRO
Aerogen, Ltd., IE
CAF
Apr 20, 2012K120051SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
Nephron Pharmaceuticals Corp.
CAF
Dec 22, 2011K112041KOO SMALL VOLUME NEBULIZER (SVN)
Koo (Shanghai) Industries Co., Ltd.
CAF

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